High-Risk Medication Consent Form

The High-Risk Medication Consent Form documents informed consent for medications that carry significant risk profiles requiring explicit patient acknowledgment before initiation. This template addresses FDA-classified high-risk medications including those under Risk Evaluation and Mitigation Strategies (REMS) programs, narrow therapeutic index drugs, immunosuppressants, biologics, teratogenic agents (iPLEDGE, Thalidomide REMS), anticoagulants, opioids, and medications requiring mandatory laboratory monitoring. The form captures the prescriber's explanation of the drug's mechanism of action, expected therapeutic benefit, and the specific adverse effects that necessitate heightened vigilance.

The consent includes structured sections for contraindication verification (pregnancy status, hepatic or renal impairment, drug interactions, allergy history), baseline laboratory requirements (CBC, CMP, LFTs, coagulation panels, serum drug levels as applicable), and the ongoing monitoring schedule with specific parameters and frequency. For REMS-enrolled medications, the form documents the patient's enrollment in the required program, completion of any mandatory patient education materials (Medication Guides, Patient-Prescriber Agreements), and acknowledgment of dispensing restrictions such as limited pharmacy networks or mandatory pregnancy testing.

Adverse effect acknowledgment uses a tiered format—common side effects, serious but less frequent risks, and rare but life-threatening complications—with specific instructions for when to seek emergency care. The form captures patient confirmation that they understand the importance of medication adherence, the dangers of abrupt discontinuation for certain drug classes, and restrictions on concurrent alcohol, supplement, or OTC medication use. Both patient and prescriber signatures with timestamps create a defensible medicolegal record.